UCN-01 in Treating Patients With Advanced or Metastatic Kidney Cancer
The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2003 by National Cancer Institute (NCI).
Recruitment status was Active, not recruiting
Information provided by:
National Cancer Institute (NCI)
First received: February 14, 2002
Last updated: January 3, 2014
Last verified: December 2003
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.
PURPOSE: Phase II trial to study the effectiveness of UCN-01 in treating patients who have unresectable stage III or stage IV kidney cancer.
||Primary Purpose: Treatment
||A Phase 2 Study Of UCN-01 In Advanced Renal Cell Carcinoma
| Study Start Date:
- Determine the efficacy of UCN-01, in terms of time to objective progression, in patients with stage IV or unresectable stage III renal cell carcinoma.
- Determine the objective response rate in patients treated with this drug.
OUTLINE: Patients receive UCN-01 IV over 3 hours on day 1. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.
PROJECTED ACCRUAL: A total of 21-61 patients will be accrued for this study within 15 months.
|Ages Eligible for Study:
||18 Years and older
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- ECOG 0-2 OR
- Karnofsky 60-100%
- WBC at least 3,000/mm^3
- Absolute neutrophil count at least 1,500/mm^3
- Platelet count at least 100,000/mm^3
- Bilirubin normal
- AST/ALT no greater than 2.5 times upper limit of normal
- Creatinine normal OR
- Creatinine clearance at least 60 mL/min
- No history of clinically significant coronary artery disease
- No symptomatic cardiac dysfunction
- No symptomatic congestive heart failure
- No unstable angina pectoris
- No cardiac arrhythmia
- No symptomatic pulmonary dysfunction
- No prior allergic reactions to compounds of similar chemical or biological composition to UCN-01
- No other uncontrolled concurrent illness
- No active or ongoing infection
- No known immune deficiency
- No psychiatric illness or social situation that would preclude study compliance
- No insulin-dependent diabetes mellitus
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception during and for 6 months after study participation
PRIOR CONCURRENT THERAPY:
- At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) and recovered
- At least 4 weeks since prior radiotherapy and recovered
- No prior mediastinal radiation
- See Disease Characteristics
- At least 4 weeks since prior nephrectomy
- No more than 2 prior systemic therapies for metastatic renal cell carcinoma
- No other concurrent investigational agents
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00030888
|UCSF Comprehensive Cancer Center
|San Francisco, California, United States, 94115 |
|Veterans Affairs Medical Center - San Francisco
|San Francisco, California, United States, 94121 |
University of California, San Francisco
||Brian I. Rini, MD
||University of California, San Francisco
No publications provided
History of Changes
|Other Study ID Numbers:
||CDR0000069208, UCSF-NCI-5522, NCI-5522
|Study First Received:
||February 14, 2002
||January 3, 2014
||United States: Federal Government
Keywords provided by National Cancer Institute (NCI):
stage III renal cell cancer
stage IV renal cell cancer
recurrent renal cell cancer
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on August 21, 2014
Carcinoma, Renal Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms by Site
Protein Kinase Inhibitors
Molecular Mechanisms of Pharmacological Action